NCT00702884

Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

Completed Phase 2 Results posted Last updated 21 March 2017

What this trial tests

Phase 2 trial testing sunitinib malate in Esophageal Cancer in 25 participants. Completed in 30 December 2013.

Timeline

30 June 2008

Primary endpoint
17 September 2013

30 December 2013

Quick facts

Lead sponsor	Tony Bekaii-Saab
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	30 June 2008
Primary completion	17 September 2013
Estimated completion	30 December 2013
Sites	1 location across United States

Drugs / interventions tested

• sunitinib malate (sunitinib-malate) — full drug profile →

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Tony Bekaii-Saab

Who can join

18 and older, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival Rate Primary · up to 24 weeks

Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks

Group	Value	95% CI
Sunitinib	7	5.6 – 11.4

Overall Response Rate Secondary · up to 4 years

The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Group	Value	95% CI
Sunitinib	10

Median Overall Survival Time Secondary · up to 4 years

The median overall survival time will be reported using the 95% confidence intervals for the parameters.

Group	Value	95% CI
Sunitinib	16.6	8.9 – 25.3

Median Progression-free Survival Time Secondary · up to 4 years

Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.

Group	Value	95% CI
Sunitinib	6.9	5.6 – 11.4

Frequency and Severity of Adverse Events Secondary · up to 4 years

The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.

Fatigue

Group	Value	95% CI
Grade 1 and 2 Adverse Events	52
Grade 3 Adverse Events	24
Grade 4 Adverse Events	0

Anemia

Group	Value	95% CI
Grade 1 and 2 Adverse Events	48
Grade 3 Adverse Events	12
Grade 4 Adverse Events	8

Thrombocytopenia

Group	Value	95% CI
Grade 1 and 2 Adverse Events	12
Grade 3 Adverse Events	12
Grade 4 Adverse Events	4

Leukopenia

Group	Value	95% CI
Grade 1 and 2 Adverse Events	32
Grade 3 Adverse Events	12
Grade 4 Adverse Events	4

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sunitinib

Serious: 25/25 (100%)

Deaths: —

Serious adverse events (9 terms)

Reaction	System	Sunitinib
Neutropenia	Blood and lymphatic system disorders	—
Anemia	Blood and lymphatic system disorders	—
Fatigue	General disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Leukopenia	Blood and lymphatic system disorders	—
GI Hemorrhage	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Hypertension	Vascular disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Sunitinib
Fatigue	General disorders	—
Nausea	Gastrointestinal disorders	—
Anemia	Blood and lymphatic system disorders	—
Anorexia	Metabolism and nutrition disorders	—
Diarrhoea	Gastrointestinal disorders	—
Leukopenia	Investigations	—
Abdominal pain	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Neutropenia	Investigations	—
Hyperglycaemia	Metabolism and nutrition disorders	—
Lymphopenia	Investigations	—
Mucositis	Gastrointestinal disorders	—
Thrombocytopenia	Injury, poisoning and procedural complications	—
GI Hemorrhage	Gastrointestinal disorders	—
Hypertension	Vascular disorders	—

Most-reported serious reactions: Neutropenia, Anemia, Fatigue, Abdominal Pain, Leukopenia, GI Hemorrhage, Nausea, Thrombocytopenia.

Data from ClinicalTrials.gov NCT00702884 adverse events section.

Sponsor's own description

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. VISTA: A Mediator of Quiescence and a Promising Target in Cancer Immunotherapy.
   Yuan L, Tatineni J, Mahoney KM, Freeman GJ. · · 2021 · cited 173× · PMID 33495077 · DOI 10.1016/j.it.2020.12.008
2. Receptor tyrosine kinases and downstream pathways as druggable targets for cancer treatment: the current arsenal of inhibitors.
   Montor WR, Salas AROSE, Melo FHM. · · 2018 · cited 80× · PMID 29455659 · DOI 10.1186/s12943-018-0792-2
3. Targeting the Microenvironment in Esophageal Cancer.
   Wang L, Han H, Wang Z, Shi L, et al · · 2021 · cited 19× · PMID 34513829 · DOI 10.3389/fcell.2021.684966
4. From Resistance to Sensitivity: Insights and Implications of Biphasic Modulation of Autophagy by Sunitinib.
   Abdel-Aziz AK, Abdel-Naim AB, Shouman S, Minucci S, et al · · 2017 · cited 19× · PMID 29066973 · DOI 10.3389/fphar.2017.00718
5. A phase II and pharmacodynamic study of sunitinib in relapsed/refractory oesophageal and gastro-oesophageal cancers.
   Wu C, Mikhail S, Wei L, Timmers C, et al · · 2015 · cited 10× · PMID 26151457 · DOI 10.1038/bjc.2015.197